Latest Drugwonks' Blog


Maybe it's being in Israel and reading too much from right to left but I get the sense that the infatuation with health IT will not make up for what appears to be an erosion in the actual treatment of real people...

For instance...

Minnesotans to receive access to a virtual clinic
April 13, 2009 | Molly Merrill, Associate Editor

ST. PAUL, MN – Minnesotans will soon have access to a virtual clinic, thanks to a partnership between Blue Cross and Blue Shield of Minnesota and American Well.

America Well's Online Care will provide Minnesotans with live interactions with physicians and other medical care providers. The virtual clinics at the worksite will emphasize treatment for common illnesses, monitor care for patients with chronic illnesses and offer preventive and wellness care.

Meanwhile....

Plan to close Northeastern Hospital stirs anger
By Josh Goldstein
Philadephia Inquirer Staff Writer

After 37 years at Northeastern Hospital, mostly in its bustling emergency room, Beverly Soska jokes that she knows many patients so well, she can diagnose them without asking a question.

Now the 67-year-old nurse who grew up near the hospital is worried about how her patients will fare if the Temple University Health System sticks to its plan to close the hospital in the city's Port Richmond section by July 1.

Northeastern is the dominant community hospital between Frankford to the north and Temple University Hospital to the west. It delivers 1,800 babies and treats about 50,000 patients in its emergency room each year, making it the ninth-busiest adult ER in the five-county area, state records show."

Oh well... If they are sick or pregnant or critically ill, they can just log in or visit a chat room....

Then there is this...

'Health Informatics Specialists' Play Key Role in Health IT Ramp-Up
Monday, April 13, 2009

Demand for "health informatics specialists" who have expertise in medical records, insurance claims, clinical care and computer programming is rapidly increasing as health care providers look to utilize the $19 billion in stimulus funding directed at implementing and expanding electronic health records, the New York Times reports.

These specialists usually start their career or education in computer programming or as health care professionals, and later earn a degree in health informatics and take midlevel or senior jobs at a hospital, doctor's office, insurance company, drug firm or other organization working with health care data.

William Hersh, chair of the Department of Medical Informatics and Clinical Epidemiology at Oregon Health and Science University, said, "The health IT people run the servers and install software, but the informatics people are the leaders, who interpret and analyze information and work with the clinical staff."

All of which is great if you are an Oracle server down for a day... But if you are a cancer survivor...well, at least you will have an electronic medical record, but not much else...

"In the United States, about 6.5 million cancer survivors are 65 years or older. Approximately 43% of these seniors survive more than 10 years, and approximately 17% survive more than 20 years from the time of their initial diagnosis, as reported in a December 2008 supplement to Cancer, "Aging in the Context of Cancer Prevention and Control."

Additionally, a shortage of oncologists creates the classic example of demand exceeding supply.

The American Society of Clinical Oncology (ASCO) predicts that by 2020, demand for oncology services will significantly outpace the supply of oncologists available to provide patient care. Driven principally by the aging population and an increasing number of cancer survivors, demand for oncology services will increase by 48% by 2020. The number of oncologists is expected to grow by only 14% in that same per-iod. This translates into a shortage of as many as 4,080 oncologists—roughly one-third of the 2005 supply."

Of the course the response is to dump more of the responsibility on primary care docs... but does anyone remember what is happening to the ranks of these medical foot soldiers ...

But those docs who try to practice quality medicine outside guidelines designed to keep care within deeply discounted limits wind up quitting or going elsewhere... And there is already a shortage of physicians to meet an aging population who are also chronically "ill" with cancer ...

And as for the lofty goal of providing integrated and preventive disease management at the primary care level there is this ...

Two-Thirds Of Primary Care Physicians Can't Get Mental Health Services For Patients

Shortages Of Mental Health Providers, Health Plan Barriers, And Lack Of Or Inadequate Coverage Cited As RoadblocksTo Mental Health Care

Bethesda, MD -- About two-thirds of U.S. primary care physicians reported in 2004-05 that they couldn't get outpatient mental health services for their patients -- a rate that was at least twice as high as for other services, according to a national study funded by the Commonwealth Fund published today as a Web Exclusive in the journal Health Affairs. Click Here to Read the Article

Conducted by Peter J. Cunningham, Ph.D., a senior fellow at the Center for Studying Health System Change (HSC), the study found that more than half of the primary care physicians reporting problems getting mental health services for their patients cited lack of or inadequate insurance coverage, health plan barriers, and shortages of mental health providers as "very important" reasons their patients couldn't get care.

Meanwhile the $700 billion "reserved" by Obama is to pay for people who already have access to health care and assumes that doctors and hospitals will take a 25 percent cut in reimbursement. It also assumes a decline in the introduction of new technologies and a more selective use of "high" cost services. Like psychiatric and cancer care.

In any event, there are fewer doctors across the board and more new technologies waiting in the wings. Investing in health IT will allow us to, perhaps, monitor the steady decline in health status and the cost of lost lives and prosperity as medical innovation is squandered. In the virtual world we are creating we all simply email our illness in. The doctor will "see" you but never touch or treat you in the new medical order. That's prevention for you.

The New SILK Road

  • 04.13.2009
One in 10 people over 65 – or 5.6 million Americans – will have Alzheimer’s Disease by 2010. Without interventional therapy, the number of cases is expected to rise to 13.5 million by 2050. As a recent CMPI study found, if we delay onset of Alzheimer's by 5 years it would be worth nearly $2 trillion to the United States.

For this sobering American pharmaco-economic data, have a look at the CMPI report, “Alzheimer’s Disease and Cost-effectiveness Analyses: Ensuring Good Value for Money? 


Currently one of the biggest hurdles providers and payers face when deciding which treatment for Alzheimer’s disease to prescribe and pay for is efficacy.  Now the public health community may have a new tool. Scientists at Washington University have developed a test to quickly assess how effective a drug is at treating Alzheimer's disease.

Until now, determining whether a drug is working has meant measuring a patient's mental functioning over a long period of time. The new measurement tool -- called stable isotope-lined kinetics (SILK) -- takes just 36 hours.

Researchers recently developed the test to find whether an Alzheimer's drug given to healthy volunteers could reduce production of a substance known as amyloid beta. Called A-beta for short, the substance is a normal byproduct of human metabolism that builds up to unhealthy levels and forms plaques in the brains of Alzheimer's patients. Scientists believe it is this buildup of plaque tangles that causes the disease's characteristic mental deterioration.

The drug currently being tested is made by Eli Lilly and is in the third phase of clinical trials. Using SILK, researchers found the drug reduced the production of the troublesome A-beta.

Smooth as SILK?  Perhaps.  But certainly an important step forward in personalized, 21st century comparative effectiveness.  A step towards achieving the four rights – the right medicine for the right patient in the right dose at the right time.

The study was released today in the online version of Annals of Neurology. The study was funded through an Eli Lilly grant.

A presidential executive order will establish a Department of Health and Human Services Office of Health Reform that will coordinate "closely" with the White House health reform office led by Nancy-Ann DeParle,

The executive order doesn’t not name the head of the new office, but cognoscenti point to Jeanne Lambrew who was originally recruited to serve as Daschle's deputy in the White House.  Since Tom’s tax troubles, she has been parked at HHS in an undefined role.

It is likely that Ms. Lambrew will act coordinator between the White House and HHS on healthcare reform-related issues.

The order also officially establishes the White House reform office. According to the executive order, the principle functions of the White House Office of Health Reform are to lead and coordinate development of the administration's policy development across executive departments and agencies, including the Domestic Policy Council, National Economic Council, Council of Economic Advisors, Office of Management and Budget, HHS and Office of Personnel Management.

The office will integrate the White House policy agenda across the federal government and coordinate public outreach to gather input from the public, from demonstration and pilot projects, and from public-private partnerships on priorities for policy measures.

We anxiously await the manner and methods this office will use to “gather input from the public” and how they chose who those publics are.

David vs. Goliath

  • 04.09.2009

Who’d a thunk it – the pharmaceutical industry recognizing that a well-funded, robust FDA is actually in their best interest?  Well, credit AstraZeneca chief executive David Brennan, who also happens to be the new chairman of PhRMA.

According to Brennan, a “strong, well-functioning” Food and Drug Administration is needed “but an understaffed and under-funded FDA is an agency in crisis.”  And, further, “we’re working hard for increased appropriations to the FDA so that it is recognized as a watchdog with a full set of teeth.”

Bravo.

Not only is this important for obvious public health reasons, but it’s also a crucial move by an industry in need of image repair – because as goes the public’s view of the FDA so too goes the Vioxx Populi.

Brennan also focused on a key point, so crucial to us all but so often ignored in the healthcare reform debate – the importance of innovation and, particularly, incremental innovation.

Speaking directly to President Obama’s call to “cure cancer,” Brennan said that “contrary to the Hollywood-like scenarios, our battle with cancer isn’t so much about spectacular breakthroughs as it is about steady, incremental progress.” However for that to continue “requires policies that are more conducive to the medical innovation that is the genesis and cornerstone of our industry…we need an environment that includes strong, well-defined intellectual property rights.”

David vs. Goliath indeed.

From the Policymed blog about David Rothman, the colleague of David Blumenthal the new health IT czar for President Obama and director of the Soros funded Institute for Medicine as Profession which believes that it's ok for medical journals to receive advertising revenue from medical device firms, biotech and drug companies but believes these industry should provide no financial support for educational or research activity even as government payors, health plans and left wing think tanks are free to do so.

The next target on IMAP's radar screen: patient advocacy groups, many of which receive all or nearly all of their funding from the drug, biotechnology or medical device companies. "We're going to address these patient advocacy groups, some of which are grass roots and some of which are astroturf," Rothman said.

Patient Advocacy groups need to be alerted that this very effective strategy as seen with Academic Medical Centers (Brennan paper 2006, followed by AAMC Taskforce 2008, followed by major reforms 2009), and now Medical Specialty Societies is a model that is working for IMAP.  This will be used against them.

They want to cause shame for doing the right thing (working with industry to develop new products that saves lives) even if it costs more in the short run. 

This Strategy should be exposed for what it really is, short sighted contempt.    Medical Societies, Academic Medical Centers and Patient Groups need to stand up against this bullying tactic; otherwise as a society we will all suffer the consequences of a lost medical research and education base.

Tom Sullivan is too kind.  This is  intellectual fascist.  Rothman represents a point of view that is toxic to the public health, that all "science" must be cleansed of the biases and viewpoints he and his fascist friends regard as the absoute truth.   The Jerry Avorns, Marcia Angells, Rothmans, etc inevitably endorse any conclusions that fit their ideology and refuse to subject their assertions to the scientific method.   ( It is the very reason that the comparative effectiveness crowd relies on a rigged approach to evaluation:  selecting only randomized trials with exclusion criteria that fail to control for variation in treatment effect and using meta-analyses to reach conclusions instead of generating hypothesis so as to reinforce the initial weakness of underpowered randomized trials.   All conclusions will show no difference in benefit among competing therapies... )

To assert that patient groups are somehow "fake" because they receive industry funding raises the question of who made Rothman and George Soros the gold standard of probity?  The ultimate measure of any individual or organization is the merit of their position, the contribution of their effort.   Does receipt of money from a currency wrecker, who has spent money to weaken the state of Israel (Soros), who himself invests billions in biotech and drug companies, qualify for knighthood compared to receiving support from companies that commercialize medical knowledge, invest in scientific research, give away billions in free medicines.  Soros -- and by extension -- Rothman and Blumenthal have profited from the profits of drug companies... 

If Rothman succeeds in his campaign of intimidation it will not "purify" medicine and thereby improve the quality of care.  There is no evidence of this cause and effect.  On the contrary there is no scientific evidence to support this assertion.  Meanwhile other countries and health systems are increasing the amount of collaboration with direct subsidies, increase patent opportunities, etc in order to promote innovation and retain scientific talent.

Rothman and his ilk are angy elites who should be shunned and attacked by the patient groups.  Once the patient groups are silenced then advocacy for faster cures will die.  What will happen next is fairly obvious.  Soros, who stood by without feeling as Nazis confiscated the property of Jews, has picked his associates well. 

A new research study from health-information company Wolters Kluwer Health reports that in the fourth quarter of 2008, U.S. patients failed to fill 6.8% of on-patent prescriptions, a 22% increase from the first quarter of 2007. Patients also abandoned prescriptions for generic drugs at a higher rate, failing to fill 4.1% of generic prescriptions. Why?  Because of “cost.”

What does “cost” mean?  Does it mean the AWP of a medicine?  Not for the 85% of Americans who have health insurance.  For them “cost” means “co-pay."

According to a story in today’s Wall Street Journal, “Higher co-payments required under health-insurance plans and other plan features helped boost the number of patients unwilling to pay for their prescriptions, according to the research.”

Not surprising.  Daniel M. Hartung, of Oregon Health & Science University, and his colleagues analyzed the effect of small co-payments -- $2 for generic and $3 for brand-name -- for prescription drugs introduced for Oregon Medicaid enrollees in 2003. The co-pay fees weren't required for patients who were unable to pay. The researchers examined pharmacy claims data on about 117,000 Medicare enrollees with depression, schizophrenia, respiratory disease, cardiovascular disease and diabetes. The patients' overall use of prescription drugs decreased by about 17 percent after introduction of the co-pay policy.

Why higher co-pays?   Because insurance companies don’t want patients to fill prescriptions for on-patent medicines. The Journal writes that “… insurers are flexing their muscle and rejecting coverage for more prescriptions. Health plans denied 10.8% of brand-name prescriptions in the 2008 fourth quarter, a 21% increase from the first quarter in 2007.

Cause and effect.

And it’s not because the medicine themselves are becoming more expensive. Consider this, from 1998 to 2003; insurance companies increased their premiums by an average of $104.62 per person. During that same time period prescription-drug costs increased by $22.48.

Are the majority of Americans with private health insurance spending more for drugs? Yes — because their insurance companies are paying less. In 2000, people under 65 with private health insurance paid 37.2 percent of the cost of their prescription drugs costs out of their own pockets. (Not surprisingly, this leads many Americans to believe that their increased out-of-pocket expenses are because of higher drug costs.) The truth is that the growth in prescription-drug co-payments outpaced the growth rate of prescription drug prices four to one.


Good for payers.  Bad for everyone else – including employers.

In June 2007, Gray Lady scribe Milt Freudenheim reported on a new study by the Integrated Benefits Institute that shows, "Employers that shift too much of the cost of drugs to workers in their company health plans could wind up losing more than they save, through absenteeism and lost productivity, according to a study by health policy researchers."

"Among the 17 employers in the study, conducted by the nonprofit Integrated Benefits Institute, more than half the workers with rheumatoid arthritis were not taking their drugs — in many cases because they considered the out-of-pocket co-payments too high.

As a result, the institute’s study found, the employers incurred $17.2 million in costs from lost productivity, 26 percent more than the estimate of what they would have spent if the workers had taken their arthritis drugs."

The headline of that New York Times article was, "Health penny wise, medical pound foolish?

Indeed.

Okay -- once more with feeling -- patients (otherwise known as "people," aka "voters") need to be on the right medicines for their conditions. And when payers interpose themselves between doctor and patient, when prescribing decisions are made by accountants based on “cost-effectiveness” studies, health outcomes decline for the individual and costs go up for our health care system.

This is not healthcare reform.

Yesterday I spotlighted how a recent article in Der Spiegel revealed the burgeoning costs that have already been produced by the latest reforms to the German health care system. Today I want to look at what the article has to say about how the reform has changed the incentives of doctors and sickness funds such that they now profit from making patients as unhealthy as possible – at least on paper.
 
With everyone required to have coverage and premiums fixed nationwide, policy experts in Germany anticipated a problem: sickness funds would look for the healthiest, youngest patients and be reluctant to cover the old or sick. Hence was born the “morbiditätsorientierten Riskoausgleichstruktur,” a mouthful that translates to “morbidity oriented risk adjustment structure” and a concept Germany has in common with countries like the Netherlands, another system sometimes held up as a model for the US.
 
However, although it set out to solve a real problem, it has created a new problem in the process. Since sickness funds get extra money for those with health problems included on the national list (about 80 at the moment), they have an incentive to seek out people with these conditions and to push patients who may be better served by a less serious diagnosis onto these categories. Consider the case of Jens Luther:
 

The 55 year old jogs, rides a racing bike, and eats carefully. As a result, he lives an almost pain free life. He is only occasionally afflicted with a sour stomach, for which each time his doctor prescribes a medicine against heartburn.
         
But with the health care reform, Luther’s condition has worsened considerably. His heart burn grew into a life-threatening reflux disease. The wiry top manager has become chronically ill.

Luther himself hasn’t noticed his terrible pain at all. He looks as fit as anyone; he’s doing great. And if he wasn’t the chairman of the board of the same sickness fund by which he is covered as a patient, he might never have found out that his health situation had deteriorated so dramatically.
 
This kind of reclassification is especially common because the extra the sickness funds receive often exceeds that they spend on care for the condition. For Luther, the sickness fund would get €1079 a year if he was healthy – but the diagnosis of reflux brings an extra €912 a year, even if his actual illness only costs a couple trips to the doctor and some simple prescriptions. The sickness fund then gets to keep the extra money. Der Spiegel reports that this is the case for many illnesses:

High blood pressure brings a bonus of €402 a year. Subtracted from that are average costs of €141 for two appointments with the primary care physician…and medicine (beta blockers, a tablet a day) – making a positive extra premium of €261 under the line.  

An asthma patient, who goes to the pneumonologist every second quarter and uses the conventional combination spray, provides a plus of €192 a year.

The diagnosis ‘psychological depression’ brings the sickness fund nothing. It’s better when the insured has a ‘light depressive episode,’ then there is almost €1000 extra.
 
So the sickness funds encourage doctors to look for patients who can be diagnosed with an illness that brings an extra premium, and share the profits, while people with conditions not on the government list are out of luck. Nor is there any incentive any longer to improve the health of those who are sick or at risk of becoming so. As Luther put it, “It’s totally absurd when the sickness funds have a bigger interest in the sick than in the healthy.”
 
You can find more information on the structure of German health care system at Biggovhealth.org, the international health care site of the Center for Medicine in the Public Interest (the public policy institute home of drugwonks.com).

While returning from a recent vacation in Berlin, an article in Germany’s leading weekly magazine Der Spiegel on the German health care system caught my eye. Entitled “Das Tollhaus” or “the madhouse,” it’s a rather scathing of exactly what has gone wrong with the recent health reforms in Germany – and a perfect indication of why Americans should spend a little less time debating health care in Canada and the UK and a little more looking elsewhere in Europe. To help in this effort, this will be the first of two posts looking at what Germans have to say about this own system.
 
To most Americans, the German health care system probably looks surprisingly familiar: citizens mostly get health coverage through their jobs, insurance is purchased from Krankenkassen or “sickness funds” that administer premiums and pay doctors and hospitals for care, and visits to the doctor often require a co-pay. But that is slowly changing in response to many of the same problems that plague the US debate, chief among them the affordability of coverage, both on a national level and an individual one. The solutions too are similar – and therein lies Germany’s instructive power for American would-be reformers.
 
Let’s start with universal care. Germany was actually a late comer to the concept and it was only as of the start of this year that every citizen had to have coverage. The results for premiums, however, have been immediate. Until this year, each sickness fund set its own premium and they averaged around 14.9 percent of payroll. But last October, a new national premium of 15.5 percent was announced for 2009, the highest ever. In July, it will go back down to 14.9 percent as part of Germany’s stimulus package.) Der Spiegel explains:
 
In past years, half a million premium payers used the ability to switch from a more expensive sickness fund to a lower priced one. In the tightly regulated sector the different premiums provided a whiff of competitions. However the government set premium now apply and already prepare the way to a single payer. Almost twenty sickness funds, including some that previously had particularly low premiums, have already disappeared. (All translations mine.)
 
Cost has also left some Germans outside of the supposedly universal system, unable to pay for coverage, ineligible for subsidies for the poor, and subject to government penalties if caught. One example is Kornelius C., 57 years old and self employed, who relies on his doctor girlfriend and her colleagues to take care of him because he is uninsured and has an unreliable income. But he isn’t alone. “The problem is that many of those concerned never know how they will pay for coverage. C. was a candidate for the new basic rate for…health coverage. The premium lies at €570 a month…He says he cannot muster this sum even with the best will.” There is one way for C. to pay for his health care coverage, he is eligible for a reduction in the premium and a government subsidy, but it would require that he cease living with his girlfriend.             
 
It isn’t only citizens who face being unable to pay health care costs. The state is also in the red, it will have to put more money than planned into the health system this year and with billions in deficits as a result. One reason is the creation of redundant structures to administer the system and “zombie bureaucrats,” who no longer have any work to do but whose jobs will exist for another three years. The sickness funds are short of funds as well, they will probably have to charge their members additional premiums. But they are given little room to collect extra money since those insured cannot be asked to pay more than one percent of their income. That may mean the loss of more sickness funds if they go broke.
 
Finally, doctors are unhappy with their reimbursement and facing the same dilemma as their American counterparts: the present structure rewards doctors “who sluice as many patients as possible in the shortest time possible through their practices. The younger the doctor’s patient clientele is, the more he earns…Potential losers are any doctor who takes time for the patients. Also retired people are bad for the budget.”
 
However, the incentive to take on healthy, easy to treat patients is only one force acting on doctors, as we will see tomorrow when I look at the perverse inducements created by the system to make patients sicker, not healthier. So stay tuned. In the meantime, for more information on the German health care system and how it works, check out BigGovHealth, the international health care site of the Center for Medicine in the Public Interest (the public policy institute home of drugwonks.com).

Why blog when all you can do is comment on events that underscore why we are closer to single payer health care than ever before....

WASHINGTON, D.C. (April 7, 2009) - Democratic and Republican party leaders and political operatives will discuss their differing perspectives on the challenges and opportunities associated with the comprehensive reform of the U.S. healthcare system during a keynote panel, titled "The Challenges and Opportunities Surrounding Healthcare Reform,” taking place Wednesday, May 20 from 12:00 – 1:45 pm at the Georgia World Congress Center during the Keynote Luncheon at the 2009 BIO International Convention.  

Moderated by Susan Dentzer of The NewsHour with Jim Lehrer, the panel will include Senator Tom Daschle, Governor Howard Dean, Senator William H. Frist, M.D, and Karl Rove. 

"This panel provides an opportunity to discuss and debate the best options and opportunities for the new administration as they move toward their goal of restructuring our nation's health care system,” said James C. Greenwood, president and CEO, BIO.  "As the Obama Administration and Congress explore how to restructure the delivery of the nation's health care services, it is important that the biotech industry is involved in the debate.”

The panel will address the road to a new health care system in the United States, providing a preview to the debates expected to take place in Congress later this year.  Panel members bring with them a vast array of experience in government service, from Congress to the Governorship and Chief of Staff to former President George W. Bush.

Great...that's exactly what we need.   Spin from spinmeisters who will tell the assembled how to behave to get a "seat at the table."  And I am sure they are all doing it for free.  I hope BIO got a good deal on the car service at least...

And how does listening to the same stuff and talking points from the New America Foundation and Rahm Emanuel (at least as far as Daschle is concerned) going to insure that biotech is involved in the debate.  Last time around biotech met face to face with President Clinton and the health proposal still called for comparative effectiveness reviews as a condition for reimbursement and use.   Now it's a done deal and BIO is fine with it.....  Have you seen those principles about "patient-centered" health care anywhere in the FCCER mission.  Anyone?

I still think it is better to stand up for principles before getting a seat at the table....And it's a lot better to give politicians a piece of your mind than to have them lecture you about how to behave in The People's House...  It is still ours...

DDMAC Goes Mental

  • 04.07.2009

If you like comparative effectiveness you’re going to love mental modeling.

The April 3 Federal Register carries a notice about a new DDMAC study, “Mental Models Study of Health Care Providers’ Understanding of Prescription Drug Effectiveness.”

The complete Federal Register notice can be found here.

The notice states:

“The Federal Food, Drug, and Cosmetic Act (the act) requires that manufacturers, packers, and distributors (sponsors) who advertise prescription human and animal drugs, including biological products for humans, disclose in advertisements certain information about the advertised product’s uses and risks. By its nature, the presentation of this risk information is likely to evoke active trade-offs by consumers and physicians, i.e., comparisons with the perceived risks of not taking a treatment, and comparisons with the perceived benefits of taking a treatment. The FDA has an interest in fostering safe and proper use of prescription drugs, which is an activity that necessitates understanding of both risks and benefits. Thus, an indepth understanding of physicians’ processing of this information, their thinking on relevant topics, and their informational needs are central to this regulatory task.”

Stipulated. 

And, according to the FR notice, the path to knowledge lies through “mental modeling:

 “… a qualitative research method that compares a model of the decision making processes of a group or groups to a model of the same process developed from expert knowledge and experience. In this study, the decision models of health care providers concerning their understanding of drug product efficacy and how they communicate their understanding to their patients will be compared to a model derived from the knowledge and experience of experts who review product labeling for the purpose of ensuring that prescribers get the information they need to make optimal prescribing decisions. FDA will use telephone interviews to determine from the health care providers the factors that influence their understanding of drug product efficacy and how they communicate their understanding to their patients. Comparing expert and health care provider responses will allow for a richer understanding of decisions determining drug product efficacy from labeling and other sources and how this understanding is communicated to their patients.”

 Like benefit/efficacy claims:

“Research and guidance to sponsors on how to present benefit and efficacy information in prescription drug advertisements is limited. For example, ‘‘benefit claims,’’ broadly defined, appearing in advertisements are often presented in general language that does not inform patients of the likelihood of efficacy and are often simply variants of an ‘‘intended use’’ statement. In a study involving a content analysis of direct-to-consumer (DTC) advertising, the researchers classified the ‘‘promotional techniques’’ used in the advertisements. Emotional appeals were observed in 67 percent of the ads while vague and qualitative benefit terminology was found in 87 percent of the ads. Only 9 percent contained data. However, for risk information, half the advertisements used data to describe side-effects, typically with lists of side effects that generally occurred in frequently. Additional research is necessary to uncover important information about how consumers understand effectiveness information about prescription drug products from DTC advertisements. This particular understanding is crucial to the risk benefit tradeoff that patients must make with the consultation of a health care professional in order to achieve the best health outcomes. The qualitative information in this Mental Models phase of the research will provide a preliminary framework and help FDA craft subsequent quantitative studies.”

That’s nice but, mental modeling notwithstanding, shouldn’t DDMAC look first to the well-understood failure of both the brief summary and fair balance/adequate provision methods it currently uses?

According to the FDA’s 2002 study, 65 percent of doctors believed that the DTC ads their patients saw confused them about the relative risks and benefits of prescription drugs—and that is a problem. In a 1999 FDA study, 56 percent of patients who saw a DTC print ad said that they read the brief summary “not at all” or “a little.” In the 2002 study that number jumped to 73 percent—an increase of seventeen percentage points. During that same three-year span, those saying they read “almost all” or “all” fell from 26 percent to 16 percent— these ten percentage points are not decimal dust by any stretch of the imagination.

In the “decimal dust” category, consider this: In 1999, 3 percent said that they weren’t aware that the brief summary even existed. In 2002 that dropped a full decimal place to 0.3 percent. In other words, more people knew that the brief summary was there, but fewer people were reading it.

And what about the FDA’s physician labeling rule? Revised in January 2006 for the first time in more than 25 years, the new format requires that the prescription information for new and recently approved products meet specific graphical requirements and includes the reorganization of critical information so physicians can find the information they need quickly. Some of the most significant changes include: A new section called Highlights to provide immediate access to the most important prescribing information about benefits and risks; A Table of Contents for easy reference to detailed safety and efficacy information; The date of initial product approval, making it easier to determine how long a product has been on the market; A toll-free number and Internet reporting information for suspected adverse events to encourage more widespread reporting of suspected side effects; A key-facts section that prompts doctors on what they should tell patients.

The problem is that this new format is prospective.  Previously approved medicines do not need to rewrite their PI in this format.

Something to think about.

Rather than mental modeling, perhaps the FDA should spend some of its precious time and resources developing a PI detailing tool to teach physicians about how to use the label as a potent patient conversation guide?

Sounds like a good project for the agency’s forthcoming “Safe Use of Drugs” initiative.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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